scholarly journals PND39 RESPONSIVENESS OF THE MULTIPLE SCLEROSIS INTERNATIONAL QUALITY OF LIFE QUESTIONNAIRE TO EXPANDED DISABILITY STATUS SCALE SCORE CHANGES IN PATIENTS WITH MULTIPLE SCLEROSIS: MONTH 12 RESULTS FROM AN INTERNATIONAL OBSERVATIONAL STUDY

2010 ◽  
Vol 13 (7) ◽  
pp. A395
Author(s):  
P Auquier ◽  
O Fernandez ◽  
H Butzkueven ◽  
P Flachenecker ◽  
E Idiman ◽  
...  
2011 ◽  
Vol 17 (8) ◽  
pp. 970-979 ◽  
Author(s):  
J Theodore Phillips ◽  
Gavin Giovannoni ◽  
Fred D Lublin ◽  
Paul W O’Connor ◽  
Chris H Polman ◽  
...  

Background: Validated measures of sustained improvements in neurological function have not been established for multiple sclerosis (MS) clinical studies. Objective: To evaluate sustained Expanded Disability Status Scale (EDSS) change as a potential indicator of neurological improvement and as an outcome measure in MS clinical studies. Methods: Analyses were performed on patients ( n = 620) from the pivotal natalizumab study AFFIRM with baseline EDSS scores ≥2.0. Cumulative probabilities of neurological improvement, defined as a 1.0-point decrease in EDSS score sustained for ≥12 weeks, were estimated by Kaplan–Meier analysis. A Cox proportional hazards model identified associated baseline factors and examined treatment effects. Results: Sustained improvement (as well as sustained worsening) in neurological disability was seen in AFFIRM patients. Sustained EDSS changes correlated well with quality of life measurements (SF36 and VAS). Natalizumab increased the cumulative probability of improvement over 2 years by 69% versus placebo (HR = 1.69; 95% CI 1.16–2.45; p = 0.006). Sensitivity analyses showed consistent benefits of natalizumab with variations in improvement magnitude and duration, and baseline disease activity. Conclusion: These analyses demonstrate that sustained EDSS improvement is an additional measure that is sensitive to treatment effects over 2 years and correlates with quality of life. Further research is warranted to validate its use as an MS study clinical outcome.


Author(s):  
Helen Beckmann ◽  
Christoph Heesen ◽  
Matthias Augustin ◽  
Christine Blome

Abstract Background: Treatment- and work-related aspects have been neglected in health-related quality of life (HRQOL) measures in multiple sclerosis (MS). We aimed to develop a brief instrument covering all important impairment-, activity-, participation-, and treatment-related aspects for use in research and practice. Methods: The 27-item Multiple Sclerosis Quality of Life Questionnaire (MS-QLQ27) was developed using open item collection, a multidisciplinary expert panel, and cognitive pretesting. It was evaluated for reliability, construct validity, and responsiveness with 100 patients presenting with relapse (84 at follow-up ~14 days later). Construct validity was analyzed by correlating the MS-QLQ27 with the disease-specific Hamburg Quality of Life Questionnaire in MS (HAQUAMS) and generic HRQOL instuments. The Expanded Disability Status Scale (EDSS) was used to analyze known-groups validity. Responsiveness was determined as the correlation of changes in MS-QLQ27 scores with changes in validation criteria. Results: Internal consistency was high (Cronbach α = 0.94 at baseline and 0.93 at follow-up). Convergent validity was supported by direction and magnitude of associations with disease-specific and generic instruments. Correlations with change in convergent criteria were strong, indicating responsiveness. The HAQUAMS showed the strongest associations with the MSQLQ27. The MS-QLQ27 showed the highest effect size compared with other patient-reported outcomes and the EDSS. It successfully distinguished between levels of disease severity. Conclusions: These results indicate that the MS-QLQ27 is a reliable, valid, and highly responsive instrument for assessing HRQOL during relapse evolution in MS. Its advantages are that it is brief yet comprehensive, covering work- and treatment-related aspects not addressed in previous measures.


2008 ◽  
Author(s):  
Oscar Fernández ◽  
Victoria Fernández ◽  
Karine Baumstarck-Barrau ◽  
Luis Muñoz ◽  
Maria del Mar Gonzalez Alvarez ◽  
...  

2008 ◽  
Author(s):  
M. C. Simeoni ◽  
P. Auquier ◽  
O. Fernandez ◽  
P. Flachenecker ◽  
S. Stecchi ◽  
...  

2001 ◽  
Vol 7 (2) ◽  
pp. 119-130 ◽  
Author(s):  
S M Gold ◽  
C Heesen ◽  
H Schulz ◽  
U Guder ◽  
A Mönch ◽  
...  

Quality of life (QoL) is discussed as an additional outcome measure in multiple sclerosis (MS). However, few questionnaires assessing disease specific QoL in MS have been published. On the basis of the literature and interviews with clinicians and MS patients, we have developed a disease specific QoL instrument and validated it in a broad range of patients with MS. In this study, a heterogeneous sample of n=237 MS patients completed the newly developed Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS, in German language) and a battery of already validated questionnaires. They further underwent neurological scoring and objective tests. By these means, we investigated its validity, appropriateness, internal consistency, and retest reliability. Internal consistency and retest coefficients were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlations with other health measures. HAQUAMS subscales and its total score distinguished between patient groups of varied disease severity, cognitive impairment, and affective symptomatology. No floor or ceiling effects were found in either of the HAQUAMS subscales. The HAQUAMS is a reliable, valid and appropriate instrument for QoL assessment in multiple sclerosis. Data of responsiveness are currently being obtained.


Sign in / Sign up

Export Citation Format

Share Document